Abstract CT248: Trastuzumab deruxtecan (T-DXd) in Chinese patients (pts) with previously treated HER2 mutant non-small cell lung cancer (NSCLC): primary analysis from the Phase 2 DESTINY-Lung05 (DL-05) trial

作者：Ying Cheng, Lin Wu, Yong Fang, Yun Fan, Xingya Li, Mingjun Zhang, Yan Yu, Yu Yao, Ruilian Xu, Jun Guo, Huaping Yang, Jian Fang, Feng Luo, Xuhong Min, Kejing Tang, Jie Hu, Yunru Chen, Rui Mao, Victor Y. Zhang, Dairong Li · 发表于：Cancer Research · 年份：2024 · DOI：10.1158/1538-7445.am2024-ct248 · 被引用次数：15 · 研究领域：Lung Cancer Treatments and Mutations、HER2/EGFR in Cancer Research、Lung Cancer Research Studies

Abstract Background: In China, non-approved therapies are used for pts with HER2 (ERBB2) mutant (HER2m) NSCLC. In DESTINY-Lung02 (DL-02), T-DXd 5.4 mg/kg showed clinical benefit with an acceptable and manageable safety profile in pts with pretreated HER2m metastatic NSCLC. DL-02 did not include any Chinese pts. We report the primary analysis of T-DXd in Chinese pts with pretreated HER2m metastatic NSCLC. Methods: In this open-label, single-arm, Phase 2 trial (NCT05246514), Chinese pts with HER2m (locally or centrally confirmed activating HER2 exon 19 or 20 mutation) metastatic non-squamous NSCLC with disease progression on or after ≥1 prior anticancer therapy (no prior HER2-directed) received T-DXd 5.4 mg/kg IV once every 3 weeks. The primary endpoint was confirmed objective response rate (ORR) by independent central review (ICR). Secondary endpoints included investigator-assessed (INV) confirmed ORR; ICR and INV duration of response, disease control rate, progression-free survival, and safety. Results: At data cutoff (September 23, 2023), 72 pts with HER2m NSCLC received T-DXd 5.4 mg/kg (full analysis set). Median T-DXd exposure was 7.9 (0.7-13.5) months. Pt characteristics and efficacy data are in the table. 71 pts had drug-related adverse events (AEs), of which 51.4% were grade (G) ≥3. Most common G≥3 AEs by grouped term: neutropenia (26.4%), thrombocytopenia (18.1%), and leukopenia (11.1%). Drug-related AEs leading to discontinuations occurred in 2 (2.8%) pts. 17 (23.6%) ...